FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENTREE NEEDLE
K Number: K914426
·
Decision Nov 27, 1991
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
14
Applicant Total
23
Review Days
56
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Basic Information
- Device Name
- ENTREE NEEDLE
- K Number
- K914426
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Core Dynamics, Inc.
- Date Received
- October 2, 1991
- Decision Date
- November 27, 1991
- Product Code
- FHO
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FHO | Pneumoperitoneum Needle | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FHO), ordered by most recent decision date.
Veress Needle
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VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE
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MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
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PNEUMO-MATIC INSUFFLATION NEEDLE
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ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCESS EXPANSION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Core Dynamics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992250 | CORE AUDIBLE TROCAR II | Sep 24, 1999 | Substantially Equivalent |
| K992190 | CORE POUCH | Sep 1, 1999 | Substantially Equivalent |
| K955490 | LAPAROSCOPIC KNITTER | Jan 22, 1996 | Substantially Equivalent |
| K953903 | LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM | Oct 20, 1995 | Substantially Equivalent |
| K953409 | LAPAROSCOPIC TROCAR | Oct 16, 1995 | Substantially Equivalent |
| K950457 | CANNUAL AND TROCAR, SUPERPUBIC | May 5, 1995 | Substantially Equivalent |
| K943172 | CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR | Jul 28, 1994 | Substantially Equivalent |
| K935826 | LAPAROSCOPIC/SUCTION/IRRIGATION PROBE | May 18, 1994 | Substantially Equivalent |
| K932118 | ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET | Mar 17, 1994 | Substantially Equivalent |
| K932021 | ENTREE CANNULA FASCIA ANCHORS | Jan 11, 1994 | Substantially Equivalent |